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Telzir (fosamprenavir calcium) – Labelling - J05AE07

Updated on site: 10-Oct-2017

Medication nameTelzir
ATC CodeJ05AE07
Substancefosamprenavir calcium
ManufacturerViiV Healthcare UK Limited  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Telzir 700 mg film-coated tablets

Fosamprenavir

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/282/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

telzir 700 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL FOR TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Telzir 700 mg film-coated tablets

Fosamprenavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/282/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Only applicable to outer carton

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR ORAL SUSPENSION

1. NAME OF THE MEDICINAL PRODUCT

Telzir 50 mg/ml oral suspension

Fosamprenavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir)

3. LIST OF EXCIPIENTS

This product also contains preservatives:

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), see leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Bottle with 225 ml oral suspension

A 10 ml graduated dosing syringe and adapter are also provided in the pack

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use

Shake bottle vigorously before use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Discard 28 days after first opening

9. SPECIAL STORAGE CONDITIONS

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/282/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

telzir 50 mg/ml

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL FOR ORAL SUSPENSION

1. NAME OF THE MEDICINAL PRODUCT

Telzir 50 mg/ml oral suspension

Fosamprenavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir)

3. LIST OF EXCIPIENTS

This product also contains preservatives:

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), see leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

225 ml oral suspension

A 10 ml graduated dosing syringe and adapter are also provided in the pack

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use

Shake bottle vigorously before use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Discard 28 days after first opening

9. SPECIAL STORAGE CONDITIONS

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/282/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Only applicable to outer carton

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